The following data is part of a premarket notification filed by Narco Air-shields with the FDA for Digital Bpm.
| Device ID | K790036 |
| 510k Number | K790036 |
| Device Name: | DIGITAL BPM |
| Classification | Transducer, Pressure, Catheter Tip |
| Applicant | NARCO AIR-SHIELDS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DXO |
| CFR Regulation Number | 870.2870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-01-08 |
| Decision Date | 1979-03-02 |